Dexamethasone

Product NDC
64980-509
11-digit product format
649800509
Labeler code
64980
Product ID
64980-509_0bde0d4d-9482-444f-8fa2-07344fc0e5ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
ELIXIR
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090891
Marketing category
ANDA
Marketing start
2011-08-01
Substance
DEXAMETHASONE
Active strength
.5 mg/5mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexamethasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui309686

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-509-24Dexamethasone237 mL in 1 BOTTLE, PLASTICELIXIR23711

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-509-24ML - Milliliter64980-50967f86f76-a065-4550-8033-f02c3b1e23bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DexamethasoneACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.]5
DexamethasoneACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MDEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.]5
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMDEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.]5
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-509DEXAMETHASONE ELIXIR [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 1 package rows20250205_7cf5c17c-a80b-4547-83b2-0d53e2b933f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309686dexAMETHasone 0.5 MG in 5 mL Oral SolutionPSN7cf5c17c-a80b-4547-83b2-0d53e2b933f711
309686dexamethasone 0.1 MG/ML Oral SolutionSCD7cf5c17c-a80b-4547-83b2-0d53e2b933f711
309686dexamethasone 0.5 MG per 5 ML Oral SolutionSY7cf5c17c-a80b-4547-83b2-0d53e2b933f711
309686dexamethasone 1 MG per 10 ML Oral SolutionSY7cf5c17c-a80b-4547-83b2-0d53e2b933f711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-509-2464980050924237 mL in 1 BOTTLE, PLASTIC (64980-509-24) 237 ml2011-08-010000-00-00NoNoCurrent